Job Description
The post will work collaboratively with the Research Nurses in providing specialist research and clinical care to research participants, assist in implementation of research programmes and record patient information. The postholder will assist in supporting a portfolio of clinical trials in a variety of specialty areas, covering activities from study set up to archiving.
The postholder will coordinate recruitment and management for research studies. These tasks will include assisting with documents to ensure studies are ready to recruit; to support data collection; recording and maintaining research data records; entering activity data and extracting information from databases; providing clinical and administrative support Research Nurses, including performing clinical test and investigations, processing and shipping samples and assisting with screening and recruitment processes. Post holders will also support – and be responsible for – relevant studies in their own right and will maintain a caseload.
This role involves high level administrative support, confidence in communicating with both internal and external stakeholders (including patients, members of the multi-disciplinary team and commercial sponsors) and an ability to manage own workload. The postholder will have their own workstreams as well as supporting the workstreams of others within the department.
- Provide clinical, administrative and data management support for research studies, in accordance with clinical trial protocols, laboratory manuals and all relevant regulatory standards.
- Work collaboratively with the Research Nurses in providing specialist research and clinical care to participants, assist in implementation of research programmes and record patient information
- Assist in supporting a portfolio of clinical trials in a variety of specialty areas, covering activities from study set up to archiving.
- Coordinate recruitment and management for research studies.
- Assisting with documents to ensure studies are ready to recruit; to support data collection; recording and maintaining research data records; entering activity data and extracting information from databases; providing clinical and administrative support Research Nurses, including performing clinical test and investigations, processing and shipping samples and assisting with screening and recruitment processes.
- Support – and be responsible for – relevant studies in own right and maintain a caseload.
- High level administrative support, confidence in communicating with both internal and external stakeholders (including patients, members of the multi-disciplinary team and commercial sponsors) and an ability to manage own workload. The postholder will have their own workstreams as well as supporting the workstreams of others within the department.
Provide The Safest Most Effective Care Possible
- Demonstrate an understanding of the importance of quality of care
- Be accountable for own actions and those of their team
Develop Responsibly, Delivering the Right Services with the Right Staff
- Have an ability to work efficiently, effectively and professionally in a multidisciplinary team
- Demonstrate that everyone’s contribution is valued
Control and Reduce the Cost Of Healthcare
- Work to ensure the care group/directorate improves efficiency and reduces waste
- Demonstrate that you will be open to improving everything that you do
Focus on Innovation for Improvement
- Have an ability to consider and implement new solutions
Displays networking skills
- Take responsibility, within own case load and as delegated by the Research Management Team, for liaising with clinical trials units regarding data queries and for checking and resolving data queries;
- Organise, manage and prioritise their own administrative caseload of clinical trials, in conjunction with the responsible Research Nurse (where applicable);
- Screen and identify potential new participants through the appropriate methods for the study; this may be attendance in clinic or review of internal databases;
- Assist and support accurate completion of trial paperwork, including: • Transcribing/exporting data from medical records to Case Report Forms (CRFs) (paper or electronic) as required by clinical trial protocols;
- Checking eligibility of patients for entry into trials and randomising/registering patients into trials according to protocol requirements;
- Ensure the timely submission of accurate and completed CRFs to the Trial Coordinating Offices, and assist with data queries as necessary;
- Co-ordinate the patient’s journey through the study, including: • Ensuring clinic appointments/tests required for patients involved in trials are carried out according to the schedule in the protocol;
- Ensuring correct laboratory kits are used for the visit;
- Preparing study-specific equipment for use;
- Be responsible for ensuring maintenance and testing of all study specific equipment takes place as per local policy;
- Assist in the maintenance of a safe environment within the clinical and office areas, promoting standards in Health & Safety;
- Assist with clinical observation as required by study protocol under the supervision (or direction) of qualified staff and participate in the care of adults requiring a range of clinical interventions, which may include venepuncture, obtaining blood pressure (manual or electronic), recording ECGs and measuring height and weight (anthropometric measurements). Training will be provided where necessary;
- Assist in the care and follow up of clinical trial patients. Where appropriate and for specific trials, the post holder is expected to work autonomously, obtaining patient informed consent to participate in a study, provide information, education and support to patients on clinical trials;
- Perform study-specific tasks within the postholder’s competence and according to the study protocol;
- Assist investigators conducting research-specific procedures, investigations and treatments;
- Consistently work to ICH GCP and all other regulatory standards;
- Maintain competence in GCP training requirements in line with local and study-specific requirements;
- To set up and implement spreadsheets that improve systems and process management;
- Update the trial databases including EDGE with the details of patients screened and recruited to trials/research. Training will be provided where necessary;
- Act as first telephone contact for enquiries about trials/research and be confident to provide non-clinical advice to patients/clients/relatives;
- Prepare documentation for monitoring visits, including electronic ordering of medical records, arranging suitable meeting rooms and acting as liaison when monitors are on site;
- Provide high standard of care and develop working relationships with other multi‑disciplinary teams and areas of the Trust involved in clinical research activity;
- Demonstrate a professional approach to work and act as a professional and responsible team member;
- Promote, monitor and maintain a clean, healthy, safe and secure environment for research participants and staff;
- Participate in internal and external working groups to develop and share evidence-based / best practice, locally, nationally and internationally;
- Develop knowledge of clinical research in the relevant disease specialties;
- Develop knowledge of ethics related to research;
- Where appropriate, undergo training in aspects of clinical trials and clinical trial administration, including ICH GCP, data collection and completion of Case Report Forms;
- Undertake mandatory and other training as required and enter onto relevant database;
- Comply with all Policies and Procedures of DBTH;
- Participate in the development and delivery of teaching programs;
- Assist / educate participants in research protocols and methodologies in order to facilitate obtaining informed consent. Assist in provision of discharge and follow-up advice;
- Recognise and use spontaneous and formal learning opportunities and share knowledge and experience with other staff;
- Develop polices relating to areas of specialty / delegated responsibilities;
- Learn and employ new clinical skills as the role develops and expands under the guidance of qualified staff;
- Recognise own strengths and limitations and ask for help when unsure and thereby act as an assertive responsible practitioner;
- Manage own workload, arranging clinic appointments and co-ordinating investigations and procedures necessary for a range of research studies;
- Be responsible for stock deliveries for own research studies (including pathology kits), ensuring stock and non-stock items are maintained at correct levels, delivered appropriately and unpacked, and that the storage areas are kept clean and tidy;
- Encourage and facilitate good practice in others by acting as a role model;
- Provide cover for sickness, absence and annual leave within and between teams;
- Any other duties, as required, in line with Band and level of responsibility;
- Provide administrative and data management support for all aspects of trial organisation, as part of an integrated member of the research team;
- Archiving of trial documentation and contacting various Departments once studies are closed down;
- Prioritise own workload effectively;
- Retrieve and present accurate data in a clear and comprehensive format, for inclusion in reports and for ad hoc enquiries;
- Work closely with the Research Management Team in compiling performance management data, including recruitment information, for all studies.